Using MRI to assess digestion in chronic intestinal pseudo-obstruction
A Case-control Study of the Gastrointestinal Response to a Liquid Test Meal in Chronic Intestinal Pseudo-obstruction, Using Magnetic Resonance Imaging
This study is testing if MRI scans after a liquid meal can help doctors diagnose chronic intestinal pseudo-obstruction and chronic constipation more quickly and accurately.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Nottingham Academic / other |
| Locations | 1 site (Nottingham, Nottinghamshire) |
| Trial ID | NCT04193735 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of standardized MRI scans after a liquid meal for diagnosing chronic intestinal pseudo-obstruction (CIPO). Participants, including those diagnosed with CIPO and chronic constipation, will undergo multiple MRI scans to assess their digestive function. The study seeks to establish a reliable clinical test that could lead to faster diagnoses for patients suffering from this debilitating condition. Participants will also complete symptom questionnaires to provide additional insights into their digestive health.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 16 and older with a clinical diagnosis of chronic intestinal pseudo-obstruction or chronic constipation.
Not a fit: Patients who cannot tolerate the liquid meal challenge or have contraindications to MRI scanning will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a quicker and more accurate diagnosis of chronic intestinal pseudo-obstruction, improving patient management.
How similar studies have performed: While there is limited research specifically on MRI for CIPO, similar imaging techniques have shown promise in assessing gastrointestinal disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to give informed consent * Sufficient level of English language to understand study information and respond to symptom questionnaires * CASES: a clinical diagnosis of primary or secondary Chronic Intestinal Pseudo-Obstruction, excluding adhesional obstruction. PICs will be asked to send clinical documentation that the diagnosis has been confirmed on crosssectional imaging. * CONTROLS: a Chronic constipation disorder diagnosed according to Rome IV criteria for functional constipation, constipation-predominant irritable bowel syndrome or opioid-induced constipation (diagnostic criteria as listed in Lacy et al 2016) Exclusion Criteria: * Inability to tolerate 400 ml liquid challenge meal (oral or through established gastrostomy; according to self-assessment) * Contra-indication to MRI scanning, such as metal implants, pacemaker etc * Pregnancy declared by candidate (no formal testing) * Inability to stop short-acting medications likely to alter small bowel motility, such as antiemetics, fast release opioids, laxatives, and anti-diarrhoeals, on the day before the study (24h before baseline scan; i.e. a total of circa 30h) as well as antibiotics for three days before the study. This only applies to long-term antibiotics commonly given for dysbiosis (small intestinal bacterial overgrowth). A short course of antibiotics given for acute infections will not be interrupted but the study day will be delayed until the course is finished. Patches, long acting formulations such as slow release medication or depot injection medication will be allowed to continue * Inability to omit parenteral nutrition for 12 hours before the fasting MRI scan (\~16h total) * Medical comorbidity that means subject will not be able to undergo multiple scans e.g. severe respiratory disorder limiting time lying flat; severe musculoskeletal disorder limiting mobility * Previous small bowel resection (excluding ileostomy, insertion of venting tube or percutaneous endoscopic gastrostomy, appendectomy or cholecystectomy). Patients who have had a colectomy for their CIPO will be eligible. * Other gastrointestinal disorder likely to alter small bowel function e.g. uncontrolled coeliac disease, Crohn's disease. A diagnosis of small intestinal bacterial overgrowth will not be a reason for exclusion. PICs will be asked to supply information on resections and comorbidities for CIPO participants.
Where this trial is running
Nottingham, Nottinghamshire
- University of Nottingham — Nottingham, Nottinghamshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Giles Major, PhD — University of Nottingham
- Study coordinator: Giles Major, PhD
- Email: giles.major@nottingham.ac.uk
- Phone: +44 115 8231035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.